Direct Healthcare Professional Communication on the risk of haematologic second primary malignancies in patients treated with thalidomide

08 April 2013

Direct Healthcare Professional Communication on the risk of haematologic second primary malignancies in patients treated with thalidomide

Dear Healthcare Professional:
Celgene Europe Limited would like to inform you of the following:

Summary

 A statistically significant increase in the risk of haematologic second primary malignancies (acute myeloid leukaemia and myelodysplastic syndromes (AML/MDS)) has been observed in an ongoing study in patients with previously untreated multiple myeloma receiving melphalan, prednisone, and thalidomide, compared with patients treated with lenalidomide plus dexamethasone.

 The risk of haematologic second primary malignancies with thalidomide increased over time, to approximately 2% after 2 years and 4% after 3 years.

 Before starting thalidomide treatment in combination with melphalan and prednisone, take into account both the benefit achieved with thalidomide and the risk of acute myeloid leukaemia and myelodysplastic syndromes.

 Carefully evaluate patients before and during treatment using standard cancer screening and provide appropriate treatment..........